The Clinical Coordinating Center contractor will continue to perform data management and analysis activities including the documentation and maintenance of appropriate confidentiality and security of files for the study and sub-studies; lead the development of the protocol and manuals of procedures development; continue to support a morbidity/mortality monitoring and adjudication system; maintain quality control and monitoring of the performance status of the Regional Centers; maintain the biological specimen laboratory; solicit and monitor laboratories; coordinate, arrange, participate in, and provide any information necessary for regular Steering Committee, Observations Study Monitoring Board, training and other necessary study meetings; and provide technical reports as required by the Government.